Safety Study of Orally Administered Curcuminoids in Adult Subjects With Cystic Fibrosis (SEER)

Tracking Information
First Submitted Date ICMJE	September 16, 2005
First Posted Date ICMJE	September 22, 2005
Last Update Posted Date	December 25, 2007
Study Start Date ICMJE	April 2005
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE; (submitted: December 18, 2007)	Safety and tolerability of 14 days of treatment with orally administered curcuminoids as assessed by adverse events, laboratory parameters, and spirometry. [ Time Frame: 14 days ]
Original Primary Outcome Measures ICMJE; (submitted: September 16, 2005)	Safety and tolerability of 14 days of treatment with orally administered Curcuminoids as assessed by:; - adverse events; - abnormal changes in laboratory parameters; - changes in spirometry.
Change History	Complete list of historical versions of study NCT00219882 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: December 18, 2007)	(1) Pharmacokinetics of repeated doses of orally administered curcuminoids. (2) Change in nasal potential difference (NPD) measurements. (3) Change in sweat chloride measurements. [ Time Frame: 14 days ]
Original Secondary Outcome Measures ICMJE; (submitted: September 16, 2005)	- Pharmocokinetics of repeated doses of orally administered Curcuminoids; - Change in nasal potential difference measurements from Screening (Visit 1) to Day 8 (Visit 3), Screening to Day 15 (Visit 4), and Day 8 to Day 15. Specifically:; * The change in low chloride plus isoproterenol response; * The change in basal PD; * The change in amiloride response; - Change in sweat chloride measurements from Baseline (at Visit 1, or at Visit 2 prior to dosing, or any day between Visits 1 and 2) to Day 15
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Safety Study of Orally Administered Curcuminoids in Adult Subjects With Cystic Fibrosis
Official Title ICMJE	A Phase I Safety and Dose Finding Study of Orally Administered Curcuminoids in Adult Subjects With Cystic Fibrosis Who Are Homozygous for Delta F508 Cystic Fibrosis Transmembrane Conductance Regulator (ΔF508 CFTR) Mutation
Brief Summary	The purpose of this study is to assess the safety of advancing doses of curcuminoids administered orally for fourteen consecutive days in adult subjects with cystic fibrosis (CF) who are homozygous for ΔF508 CFTR.
Detailed Description	The drug substance being studied is curcumin. Curcumin (diferuloylmethane) is a major constituent in the spice turmeric, which is used as a food worldwide. The pharmacologic rationale for studying curcumin for the treatment of cystic fibrosis is the potential for curcumin to help correct a deficiency of the cystic fibrosis transmembrane regulator (CFTR) protein. Cystic fibrosis results from a mutation of the CFTR gene, which produces abnormal CFTR protein that does properly transport chloride ion and water in the lung leading to abnormal mucus production. Curcumin is a potent inhibitor of the endoplasmic reticulum (ER) Ca2+ pump, and lowers ER calcium concentration. This may allow abnormal CFTR protein to function properly as a chloride channel and correct the cystic fibrosis defect. If this is successful, this effect could be measured as a decrease in the nasal potential difference (NPD) and sweat chloride in cystic fibrosis patients. The primary objective of this study is to assess the safety of advancing doses of curcuminoids administered orally for fourteen consecutive days in adult subjects with cystic fibrosis (CF) who are homozygous for ΔF508 CFTR. The secondary objectives are to obtain pharmacokinetic data for oral curcumoniods in CF subjects and to assess the effectiveness of curcuminoids to alter nasal potential difference (NPD) and seat chloride concentrations.
Study Type ICMJE	Interventional
Study Phase	Phase 1
Study Design ICMJE	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Cystic Fibrosis
Intervention ICMJE	Drug: standardized turmeric root extract; 1.5 gm of standardized tumeric root extract three times per day for seven consecutive days, followed by 3 gm of standardized tumeric root extract three times per day for seven consecutive days; Other Name: AFI Curcuminoids
Study Arms	Experimental: 1; standardized turmeric root extract; Intervention: Drug: standardized turmeric root extract
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: December 18, 2007)	11
Original Enrollment ICMJE; (submitted: September 16, 2005)	10
Actual Study Completion Date	January 2006
Primary Completion Date	Not Provided
Eligibility Criteria ICMJE	Inclusion Criteria: Male or female 18 - 40 years of age.; Documented history of being homozygous for ΔF508 CFTR genotype.; Able to perform spirometry maneuvers, and have a forced expiratory volume at 1 second (FEV1) greater than or equal to 30% of predicted normal for age, gender, and height (Knudson standards) at screening.; Oxygen saturation (as measured by pulse oximetry) > 90% on room air at screening.; Clinically stable with no evidence of acute upper or lower respiratory tract infection.; Non-smoker for at least 6 months prior to screening.; Able to understand and sign a written informed consent and comply with the requirements of the study. Exclusion Criteria: Diagnosis of acute pulmonary exacerbation (PE) requiring antibiotic intervention within 4 weeks prior to screening.; Patient reported history of viral upper respiratory tract infection within 2 weeks prior to screening.; History of major complications of lung disease (including recent massive hemoptysis or pneumothorax) within two months prior to screening Visit.; Acute nosebleeds within 14 days prior to screening.; Nasal surgery within 4 weeks prior to screening.; Begun use of nasal antibiotics, nasal steroids, nasal cromolyn, nasal atrovent, nasal phenylephrine, or oxymetazoline within 14 days prior to screening.; Chest x-ray at screening or within 3 months of screening with abnormalities suggesting clinically significant active pulmonary disease other than cystic fibrosis, and/or new CF-specific changes including atelectasis, small pneumothoraces, or pneumonia.; EKG at screening which shows clinically significant abnormality including prolonged QTc, bundle branch block, rhythm other than sinus, evidence of ischemic heart disease.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 40 Years (Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00219882
Other Study ID Numbers ICMJE	SEER-106
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Chris Goss, MD, University of Washington
Study Sponsor ICMJE	Ramsey, Bonnie, MD
Collaborators ICMJE	Seer Pharmaceuticals; CF Therapeutics Development Network Coordinating Center; Cystic Fibrosis Foundation Therapeutics
Investigators ICMJE	Principal Investigator: Chris Goss, MD, MSc University of Washington
PRS Account	Ramsey, Bonnie, MD
Verification Date	December 2007
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP